Duns Number:251731105
Device Description: Q-Snor component for use during sleep disorder studies as a measure of snoring for recordi Q-Snor component for use during sleep disorder studies as a measure of snoring for recording onto a data acquisition system.
Catalog Number
0544
Brand Name
BRAEBON Q-Snor Interface
Version/Model Number
0544
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K020312
Product Code
MNR
Product Code Name
Ventilatory Effort Recorder
Public Device Record Key
35f64bcc-429a-45c8-8918-7b9f01a3c988
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |